Enforcing pharmaceutical and biotech patent rights in China

Companies with a significant intellectual property stake in China should put in place an effective protection and enforcement strategy against local and overseas competitors.

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References

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    Yidong, G. Science 309, 735 (2005).

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    World Intellectual Property Organization (WIPO). The Paris Convention, Madrid Agreement for the International Registration of Marks, the Berne Convention, the Patent Cooperation Treaty (PCT), WIPO Copyright Treaty, WIPO Performance and Phonograms Treaty and the World Trade Organization.

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    Art. 25 of Patent Law of the People's Republic of China (2000).

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    Guo, J. & Xin, H. Science 314, 1232–1235 (2006).

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    According to statistics from the Supreme People's Court of China.

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    Art. 11 of Patent Law of the People's Republic of China (2000).

  10. 10

    Art. 63(2)–(4), supra.

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    Rule 48 of Interpretations of the Supreme People's Court Concerning Several Issues on Application of Law to Trials of Civil Disputes over Patent Infringement (Discussion Draft, 10/27–29/2003).

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    Section 35 USC 271(e)(1). See Merck KGaA vs. Integra Life Sciences, 545 US 193 (2005); 496 F.3d 1334 (Fed. Cir. 2007) and Proveris Scientific Corp v. InnovaSystems, Inc., No. 2007-1428 (Fed. Cir., 2008).

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    Art. 63 of Patent Law of the People's Republic of China (2000).

  15. 15

    Art. 63(1), supra.

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    Art. 56, supra. See also, Rule 78, Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  17. 17

    Rule 78 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  18. 18

    Rule 81, supra.

  19. 19

    For example, Art. 58 of Patent Law of the People's Republic of China (2000).

  20. 20

    Rule 82 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  21. 21

    Art. 62 of Patent Law of the People's Republic of China (2000).

  22. 22

    Art. 57, supra.

  23. 23

    Rule 63 of Interpretations of the Supreme People's Court Concerning Several Issues on Application of Law to Trials of Civil Disputes over Patent Infringement (Discussion Draft, 10/27–29/2003).

  24. 24

    Tonghua Antaike Biological Engineering Co., Ltd. v. Lily France S.A.A., 2006, People's Republic of China Beijing Municipal No. 1 Intermediate People's Court, Judgment No. 7493.

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    Art. 61 of Patent Law of the People's Republic of China (2000).

  27. 27

    Art. 60, supra.

  28. 28

    Rule 21 of Several Provisions of the Supreme People's Court on Issues Relating to Application of Law to Adjudication of Cases of Patent Disputes (2001).

  29. 29

    Art. 45 of Patent Law of the People's Republic of China (2000).

  30. 30

    Art. 46, supra.

  31. 31

    Id.

  32. 32

    Rule 64 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  33. 33

    Art. 22 of Patent Law of the People's Republic of China (2000).

  34. 34

    Id.

  35. 35

    Id.

  36. 36

    Art. 26, supra.

  37. 37

    Art. 33, supra.

  38. 38

    Rule 25 of Implementing Regulations of the Patent Law of the People's Republic of China (2001).

  39. 39

    Art. 47 of Patent Law of the People's Republic of China (2000).

  40. 40

    The SFDA was as a restructured agency from its predecessor, China State Drug Administration, which was established in 1998 from the merger of the Ministry of Health's Department of Drug Administration with the State Pharmaceutical Administration of China.

  41. 41

    Approved by the State Council and promulgated by the State Medicine Administration in December, 1992, and became effective as of Jan. 1, 1993.

  42. 42

    Art. 1 of Regulations on Administrative Protection for Pharmaceuticals (1993).

  43. 43

    Art. 3, supra.

  44. 44

    Art. 5, supra.

  45. 45

    Art. 11, supra.

  46. 46

    Art. 13, supra.

  47. 47

    Art. 19, supra.

  48. 48

    Art. 15, supra.

  49. 49

    Art. 66, Provisions for Drug Registration (SFDA Order No. 28, 2007).

  50. 50

    Art. 71 and Art. 69, supra.

  51. 51

    Art. 20, supra.

  52. 52

    Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98–417, 1984 Stat. 1538 (codified as amended in scattered sections of 21 & 35 USC). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use.

  53. 53

    Legislative activities in the US regarding biosimilars include “Pathway for Biosimilars Act” (H.R. 5629); “Biologics Price Competition and Innovation Act of 2007” (S. 1695); “Patient Protection and Innovative Biologic Medicines Act of 2007” (H.R. 1956); and “Access to Life-Saving Medicine Act” (H.R. 1038).

  54. 54

    Art. 18 of Provisions for Drug Registration (SFDA Order No. 28, 2007).

  55. 55

    Art. 12, supra.

  56. 56

    According to SIPO, the third major reform to China's Patent Law is expected to go into effect in early 2009. http://www.sipo.gov.cn/sipo2008/yw/2008/200807/t20080731_413639.html

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The content of this article is not to be attributed to the authors' current, past or future clients or employers, nor should it be viewed or regarded as legal advice to anyone.

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Zhang, Y., Deng, M. Enforcing pharmaceutical and biotech patent rights in China. Nat Biotechnol 26, 1235–1240 (2008). https://doi.org/10.1038/nbt1108-1235

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